Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer

This study has been terminated.

(study not feasible with low accrual. DSMB recommended closure)

Sponsor:

University of South Florida

ClinicalTrials.gov Identifier:

NCT00949117

First Posted: July 30, 2009

Last Update Posted: April 2, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.

PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.

Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24 [ Time Frame: 24 weeks ]

Change in Weight for Age Z-score From Baseline Through 24 Weeks [ Time Frame: Baseline and 24 weeks ]

Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.

Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Drug: cyproheptadine hydrochloride

Given orally

Other Name: cyproheptadine HCl

Experimental: cyproheptadine HCl & PediaSure or Ensure

Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Dietary Supplement: Ensure

Given orally

Other Name: nutritional supplement drink

Dietary Supplement: PediaSure

Given orally

Other Name: nutritional supplement drink (pediatric)

Drug: cyproheptadine hydrochloride

Given orally

Other Name: cyproheptadine HCl

Detailed Description:

OBJECTIVES:

Primary

To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.

Secondary

To compare patterns of body composition and weight change in patients treated with these regimens.

To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.

To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.

Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.

Eligibility

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Ages Eligible for Study:

2 Years to 17 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

≥ 2 years and < 18 years of age at the time of admission to the study

Meets one of the following criteria:

documented history of unintended weight loss > 5% presumed secondary to cancer/treatment-related therapy within three months

Patients who will complete concomitant cancer treatment during this study's 4-week intervention are not eligible

If patients are receiving concomitant cancer treatment, they should be scheduled to get at least another 4 weeks of treatment in order to reach the primary endpoint

If patients have already completed cancer treatment, they need to be enrolled within 8 weeks of completing therapy.

Predicted life expectancy of at least 6 months

EXCLUSION CRITERIA:

Currently taking any of the study agents (cyproheptadine hydrochloride (CH), PediaSure, or Ensure) or have taken any of the study agents during the past 3 weeks

History of anorexia nervosa or bulimia

Initiation of other appetite enhancing agents including steroids prescribed for the intent of weight gain, i.e. Megace, is not allowed during this study

Children receiving steroids as part of their daily cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen or in other pulse steroid therapy is allowed during the study.

Use of other forms of nutrition therapies, e.g. total parenteral nutrition (TPN) or enteral tube feedings within 3 weeks of study entry or during study